Evidence map›Paper›PMID 34322775›Full record

ArticleInvestigational new drugs2021

Phase I trial of copanlisib, a selective PI3K inhibitor, in combination with cetuximab in patients with recurrent and/or metastatic head and neck squamous cell carcinoma.

Grégoire Marret, Nicolas Isambert, Keyvan Rezai, Jocelyn Gal, Esma Saada-Bouzid, Frédéric Rolland, Maggy Chausson, Edith Borcoman, Marie Alt, Jerzy Klijanienko and 6 more

Abstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Investigational new drugs, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 20 papers.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed
1.3field-weighted citation impact, top 20% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 24 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 6 institutions in 1 country.

Grégoire MarretDepartment of Drug Development and Innovation (D3i), Institut Curie, Paris & Saint-Cloud, France.
Nicolas IsambertDepartment of Medical Oncology, Centre Georges-François Leclerc, Dijon, France.
Keyvan RezaiRadio-Pharmacology Department, Institut Curie, Saint Cloud, France.
Jocelyn GalEpidemiology and Biostatistics Unit, Centre Antoine Lacassagne, Nice, France.
Esma Saada-BouzidDepartment of Medical Oncology, Centre Antoine Lacassagne, Université Côte D'Azur, Nice, France.
Frédéric RollandDepartment of Medical Oncology, Institut René Gauducheau, Saint Herblain, France.
Maggy ChaussonUNICANCER, Paris, France.
Edith BorcomanDepartment of Drug Development and Innovation (D3i), Institut Curie, Paris & Saint-Cloud, France.
Marie AltDepartment of Drug Development and Innovation (D3i), Institut Curie, Paris & Saint-Cloud, France.
Jerzy KlijanienkoDepartment of Pathology, Institut Curie, Paris, France.
Damien VansteeneDepartment of Medical Oncology, Institut René Gauducheau, Saint Herblain, France.
Joël GuigayDepartment of Medical Oncology, Centre Antoine Lacassagne, Université Côte D'Azur, Nice, France.
Maud KamalDepartment of Drug Development and Innovation (D3i), Institut Curie, Paris & Saint-Cloud, France.
Ivan BiècheDepartment of Genetics, Institut Curie, Paris Descartes University, Paris, France.
Christophe Le TourneauDepartment of Drug Development and Innovation (D3i), Institut Curie, Paris & Saint-Cloud, France. christophe.letourneau@curie.fr.
UNICANCER Head, Neck Group
Institut Curie · FRCentre Antoine Lacassagne · FRInstitut Génétique Nantes Atlantique · FRCentre Georges François Leclerc · FRUniCancer Group · FRUniversité Paris Cité · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background The phosphatidylinositol-3 kinase pathway is often altered in head and neck squamous cell carcinoma (HNSCC), and is involved in the resistance to EGFR inhibitors. Objective We investigated the dose-limiting toxicities (DLTs), maximum tolerated dose, pharmacokinetics, and preliminary efficacy of the combination of copanlisib, an intravenous, pan-class I PI3K inhibitor, with the anti-EGFR monoclonal antibody cetuximab in recurrent and/or metastatic HNSCC patients in a phase I dose-escalation trial. Patients and methods Copanlisib was given intravenously on days 1, 8, and 15 of 28-day cycles at the dose of 45 mg and 30 mg, in combination with standard doses of weekly cetuximab (400 mg/m

Indexed as

AgedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsArea Under CurveCetuximabDose-Response Relationship, DrugFemaleHalf-LifeHead and Neck NeoplasmsHumansMaleMaximum Tolerated DoseMiddle AgedPhosphoinositide-3 Kinase InhibitorsPyrimidinesQuinazolinesAntineoplastic AgentsCetuximabcopanlisibPhosphoinositide-3 Kinase InhibitorsPyrimidinesQuinazolinesCetuximabCopanlisibEGFRHead and neck cancerPhase IPhosphatidylinositol-3 kinase (PI3K)

Identifiers

PMID34322775
OpenAlexW3177225317

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.